Title: Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial
Author: Vladimir Lomivorotov, Igor Kornilov, Vladimir Boboshko, Vladimir Shmyrev, Ilya Bondarenko, Ilya Soynov, Alexey Voytov, Stanislav Polyanskih, Oleg Strunin, Alexander Bogachev-Prokophiev, Giovanni Landoni, Caetano Nigro Neto, Gretel Oliveira Nicolau, Leonardo Saurith Izquierdo, Vinícius Nogueira Nascimento, Zhang Wen, Hu Renjie, Zhang Haibo, Vladlen Bazylev, Mikhail Evdokimov, Shahrijar Sulejmanov, Aleksei Chernogrivov, Dmitry Ponomarev
Abstract: Importance Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain.
Objective To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery.
Design, Setting, and Participants The Intraoperative Dexamethasone in Pediatric Cardiac Surgery was an investigator-initiated, double-blind, multicenter randomized trial that involved 4 centers in China, Brazil, and Russia. A total of 394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018.
Interventions The dexamethasone group (n=194) received 1 mg/kg of dexamethasone; the control group (n=200) received an equivolume of 0.9% sodium chloride intravenously after anesthesia induction.
Main Outcomes and Measures The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery. There were 17 secondary end points, including the individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization.
Results All of the 394 patients randomized (median age, 6 months; 47.2% boys) completed the trial. The primary end point occurred in 74 patients (38.1%) in the dexamethasone group vs 91 patients (45.5%) in the control group (absolute risk reduction, 7.4%; 95% CI, 0.8% to 15.3%; hazard ratio, 0.82; 95% CI, 0.60 to 1.10; P=.20). Of the 17 prespecified secondary end points, none showed a statistically significant difference between groups. Infections occurred in 4 patients (2.0%) in the dexamethasone group vs 3 patients (1.5%) in the control group.
Conclusions and Relevance Among infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of dexamethasone, compared with placebo, did not significantly reduce major complications and mortality at 30 days. However, the study may have been underpowered to detect a clinically important difference.